Ampicillin Sodium and Sulbactam Sodium

Class: Aminopenicillins
VA Class: AM111
Chemical Name: 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, [2S-[2α,5α,6β(S*)]]-6-[(Aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-, mixt. with (2S-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid 4,4-dioxide
CAS Number: 94935-63-4
Brands: Unasyn

Introduction

Antibacterial; β-lactam antibiotic; fixed combination of ampicillin (an aminopenicillin) and sulbactam (a β-lactamase inhibitor).^{1 3 29 30 64 69}

Uses for Ampicillin Sodium and Sulbactam Sodium

Bone andJoint Infections

Treatment of bone and joint infections† (including osteomyelitis and/or septic arthritis) caused by susceptible β-lactamase-producing bacteria.^{30 58 62 64 90}

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible β-lactamase-producing Escherichia coli, Klebsiella (including K. pneumoniae), Bacteroides (including B. fragilis), or Enterobacter.^{1 4 29 30 47 53 64 82 85}

May be as effective as multiple-drug regimens for treatment of less severe intra-abdominal infections, but an aminoglycoside probably should be used concomitantly for empiric therapy in more serious intra-abdominal infections, including hospital-acquired infections, pending results of in vitro susceptibility tests.^{64 101 102}

Gynecologic Infections

Treatment of serious gynecologic infections (e.g., endometritis, postpartum endomyometritis, posthysterectomy pelvic cellulitis, vaginal cuff abscess, salpingitis, tubo-ovarian abscess, pelvic peritonitis or abscess, surgical wound sepsis) caused by susceptible β-lactamase-producing E. coli or Bacteroides (including B. fragilis).^{1 49 50 52 54 55 56 74 75 76 83 91}

Treatment of pelvic inflammatory disease (PID).^{6 7} When a parenteral regimen is indicated for PID, CDC and others recommend a regimen of IV ampicillin and sulbactam and IV doxycycline as an alternative^{6 7} since it provides good coverage against C. trachomatis, N. gonorrhoeae, and anaerobes and is effective for tubo-ovarian abscess.⁶

Respiratory Tract Infections

Treatment of lower respiratory tract infections† (including pneumonia,^{57 77 84 87 89} bronchitis,^{29 57 61 84 87 89} acute exacerbations of chronic bronchitis,^{84 87} bronchiectasis)^{84 87} caused by susceptible Staphylococcus, Streptococcus, Haemophilus influenzae, H. parainfluenzae, Moraxella catarrhalis, E. coli, Klebsiella, or Proteus mirabilis.^{77 81 84 87 89}

Has been used for treatment of respiratory tract infections (e.g., pneumonia, tracheobronchitis) or bacteremia caused by Acinetobacter† resistant to imipenem and other anti-infectives.⁹³ Imipenem or meropenem with or without an aminoglycoside usually are recommended for treatment of infections caused by susceptible Acinetobacter.^{4 101}

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (e.g., wound infections, cellulitis, ulcers, abscesses, furunculosis) caused by susceptible β-lactamase-producing S. aureus,^{1 58 71 87 90} Enterobacter,¹ E. coli,^{1 58 71 87 90} Klebsiella (including K. pneumoniae),^{1 71} P. mirabilis,^{1 58 71 90} Bacteroides (including B. fragilis),¹ or Acinetobacter.^{1 29 30 48 58 61 64 86 87 90}

Also has been used for treatment of skin and skin structure infections caused by susceptible S. epidermidis†,^{58 71 87 90} S. warneri†,^{58 90} Enterococcus faecalis†,^{58 71 90} Citrobacter†,⁷¹ or Morganella morganii†.^{58 90}

Bite Wounds

Empiric treatment of animal or human bites†.^{4 5} Active against most likely bite pathogens, including anaerobes, Staphylococcus, Eikenella corrodens, Pasteurella multocida.⁵

Alternative for treatment of infections caused by P. multocida† or E. corrodens†.^{4 5}

Gonorrhea and Associated Infections

Has been used for treatment of uncomplicated gonorrhea† caused by susceptible Neisseria gonorrhoeae.^{29 30 47 79 80 94 95} However, penicillins, including ampicillin sodium and sulbactam sodium, are not included in current CDC recommendations for treatment of gonorrhea.⁶

Meningitis

Alternative for treatment of meningitis† caused by susceptible N. meningitidis, H. influenzae, or S. pneumoniae.^{78 59 87} Other drugs generally preferred and some clinicians strongly discourage use of ampicillin and sulbactam in CNS infections.¹⁰¹ Treatment failures reported when used for treatment of meningitis caused by K. pneumoniae.³⁵

Perioperative Prophylaxis

Perioperative prophylaxis† to reduce the incidence of infections in patients undergoing contaminated or potentially contaminated surgery (e.g., GI or biliary tract surgery, vaginal or abdominal hysterectomy, transurethral prostatectomy).^{29 30 51 60 98 99 100} Other anti-infectives with narrower spectra of activity (e.g., cephalosporins) generally preferred when prophylaxis is indicated in such procedures.^{96 97}

Ampicillin Sodium and Sulbactam Sodium Dosage and Administration

Administration

Administer by slow IV injection or IV infusion or by IM injection.¹

Dosage is the same for IM and IV administration;¹ higher serum concentrations usually are attained with IV administration^{1 30 33 46 63 67} and IV route generally preferred, especially for severe infections.^{101 102}

For solution and drug compatibility information, see Compatibility under Stability.

IV Administration

Reconstitution and Dilution

IV solutions are prepared by reconstituting vials containing 1.5 or 3 g of combined ampicillin and sulbactam with sterile water for injection to provide solutions containing 375 mg/mL (250 mg of ampicillin and 125 mg of sulbactam per mL).¹ An appropriate volume of the reconstituted solution should then be immediately diluted with a compatible IV solution to yield solutions containing 3–45 mg/mL (2–30 mg of ampicillin and 1–15 mg of sulbactam per mL).¹

ADD-Vantage vials containing 1.5 or 3 g of combined ampicillin and sulbactam should be reconstituted according to the manufacturer's directions with the 0.9% sodium chloride injection diluent provided.¹

Infusion bottles containing 1.5 or 3 g of combined ampicillin and sulbactam may be reconstituted to the desired concentration with a compatible IV solution (see Solution Compatibility under Stability.)¹

IV solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.¹

Rate of Administration

For IV injection, given slowly over a period of ≥10–15 minutes.¹

IV infusions should be infused slowly over 15–30 minutes.¹

IM Administration

IM injections should be made deeply into a large muscle mass.¹

Reconstitution

IM solutions are prepared by reconstituting vials containing 1.5 or 3 g of combined ampicillin and sulbactam with 3.2 or 6.4 mL, respectively, of sterile water for injection or 0.5 or 2% lidocaine hydrochloride injection to provide a solution containing 375 mg of the drug per mL (250 mg of ampicillin and 125 mg of sulbactam per mL).¹ Use of lidocaine hydrochloride can minimize local pain associated with IM injection of the drug.^{47 64 92}

IM solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.¹ IM solutions should be used within 1 hour after reconstitution.¹

Dosage

Available as fixed combination containing ampicillin sodium and sulbactam sodium; dosage generally expressed in terms of the total of the ampicillin and sulbactam content of the fixed combination.¹ Potency of both ampicillin sodium and sulbactam sodium are expressed in terms of the bases.¹

Pediatric Patients

General Pediatric Dosage

IV

Children ≥1 month of age†: AAP recommends 100–150 mg/kg of ampicillin daily in 4 divided doses for treatment of mild to moderate infections or 200–400 mg/kg of ampicillin daily in 4 divided doses for treatment of severe infections.⁵

Skin and Skin Structure Infections

IV

Children ≥1 year of age: 300 mg/kg daily (200 mg of ampicillin and 100 mg of sulbactam) in equally divided doses every 6 hours.¹

Manufacturer recommends that IV treatment in pediatric patients not exceed 14 days; in clinical studies, most children received an appropriate oral anti-infective after an initial IV regimen of ampicillin and sulbactam.¹

Acute Pelvic Inflammatory Disease

IV

Adolescents: 3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours in conjunction with doxycycline (100 mg orally or IV every 12 hours).⁶ Parenteral regimen may be discontinued 24 hours after clinical improvement; oral doxycycline (100 mg twice daily) should be continued to complete 14 days of therapy.⁶

Adults

General Adult Dosage

Intra-abdominal, Gynecologic, or Skin and Skin Structure Infections

IV or IM

1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours.¹

Acute Pelvic Inflammatory Disease

IV

3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours in conjunction with doxycycline (100 mg orally or IV every 12 hours).^{6 7} Parenteral regimen may be discontinued 24 hours after clinical improvement; oral doxycycline (100 mg twice daily) should be continued to complete 14 days of therapy.^{6 7}

Prescribing Limits

Pediatric Patients

IV

Maximum sulbactam dosage is 4 g (i.e., 8 g of ampicillin and 4 g of sulbactam in fixed combination) daily.¹

Duration of therapy should be ≤14 days.¹

Adults

IV or IM

Maximum sulbactam dosage is 4 g (i.e., 8 g of ampicillin and 4 g of sulbactam in fixed combination) daily.¹

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with renal impairment.^{1 3}

Patients with renal impairment should receive the usually recommended dose but these doses should be given less frequently than usual; dosing intervals are based on the patient’s Cl_cr.¹ The manufacturer recommends that patients with Cl_cr ≥30 mL/minute per 1.73 m² should receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) every 6–8 hours and patients with Cl_cr 15–29 or 5–14 mL/minute per 1.73 m² receive these doses every 12 or 24 hours, respectively.¹

Some clinicians suggest that patients undergoing hemodialysis receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) once every 24 hours and that the dose should preferably be given immediately after dialysis.^{34 72}

Geriatric Patients

No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)

Cautions for Ampicillin Sodium and Sulbactam Sodium

Contraindications

• 
  

  Known hypersensitivity to any penicillin.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi (e.g., Pseudomonas, Candida).¹ Discontinue and institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives may permit overgrowth of clostridia.^{1 103 104 105 106 107} Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.^{1 103 104 105 106 107} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.^{1 HID 103 104 105 106 107}

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.^{1 3 21 15}

Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs.¹ Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.^{1 3 13 16}

If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Mononucleosis

Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.¹

Sodium Content

Each 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) contains approximately 5 mEq (115 mg) of sodium.¹

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B.¹

Lactation

Both ampicillin and sulbactam distributed into milk in low concentrations.¹ Use with caution.¹

Pediatric Use

Safety and efficacy of IM ampicillin and sulbactam have not been established for any indication in pediatric patients.¹

Safety and efficacy of IV ampicillin and sulbactam have not been established in children <1 year of age.¹ Safety and efficacy of the IV route have been established for treatment of skin and skin structure infections in children ≥1 year of age, but have not been established for any other indication in this age group.¹

Adverse effects reported in pediatric patients similar to those reported in adults.¹

Geriatric Use

Serum half-lives of ampicillin and sulbactam slightly longer in geriatric adults than in younger adults;^{3 31} not considered clinically important in geriatric patients with renal function normal for their age.⁶⁶

Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.¹ Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.¹

No dosage adjustments except those related to renal function.¹ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Dosage adjustments necessary in renal impairment.¹

Common Adverse Effects

Local reactions (pain at IM or IV injection sites, thrombophlebitis);^{1 29 30 57 77 79 80 87 92} GI effects (diarrhea, nausea, vomiting),^{1 29 30 92} rash.^{1 29}

Interactions for Ampicillin Sodium and Sulbactam Sodium

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Allopurinol	Possible increased incidence of rash reported with ampicillin;1 14 19 22 data not available regarding ampicillin and sulbactam 1	Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients1 Clinical importance has not been determined;27 some clinicians suggest that concomitant use of ampicillin and allopurinol should be avoided if possible14
Aminoglycosides	In vitro evidence of synergistic antibacterial effects against enterococci;9 10 11 24 used to therapeutic advantage in treatment of endocarditis and other severe enterococcal infections8 10 24 Potential in vitro and in vivo inactivation of aminoglycosidesHID 3 70
Chloramphenicol	In vitro evidence of antagonism with ampicillin12 28	Clinical importance unclear12 27
Hormonal contraceptives	Possible decreased efficacy of estrogen-containing oral contraceptives and increased incidence of breakthrough bleeding reported with ampicillin3	Some clinicians suggest that a supplemental method of contraception be used in patients receiving oral contraceptives and ampicillin concomitantly; other clinicians state that most women taking oral contraceptives probably do not need to use alternative contraceptive precautions while receiving ampicillin17 18 25 26
Methotrexate	Possible decreased renal clearance of methotrexate with penicillins; possible increased methotrexate concentrations and hematologic and GI toxicity109	Monitor closely if used concomitantly109
Probenecid	Decreased renal tubular secretion of ampicillin and sulbactam; increased and prolonged ampicillin and sulbactam concentrations may occur1 3 29 30 33 65 92
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1
Tests for uric acid	Possible falsely increased serum uric acid concentrations when copper-chelate method is used;20 phosphotungstate and uricase methods appear to be unaffected by ampicillin20

Ampicillin Sodium and Sulbactam Sodium Pharmacokinetics

Absorption

Bioavailability

Peak ampicillin serum concentrations attained with ampicillin and sulbactam are similar to those attained with ampicillin alone.¹

Peak serum concentrations of ampicillin and sulbactam attained immediately following completion of a 15-minute IV infusion of ampicillin and sulbactam.^{1 63}

Following IM injection, both drugs are rapidly and almost completely absorbed;^{30 33 46 67} peak serum concentrations of ampicillin and sulbactam generally attained within 30–40 and 30–52 minutes, respectively.^{30 67}

Peak serum concentrations and AUCs of ampicillin and sulbactam are slightly higher in geriatric patients than in younger adults, presumably because of reduced renal clearance in the elderly.^{3 31}

Distribution

Extent

Both ampicillin and sulbactam widely distributed into fluids and tissues,^{1 3 29 30 33} including peritoneal fluid,^{1 3 29 30 43 44 60 65} blister fluid,^{1 3 29 30 36 65 68} tissue fluid,¹ sputum,^{3 30} middle ear effusion,^{3 65} intestinal mucosa,^{1 30 45 65} bronchial wall,⁴² alveolar lining fluid,⁴² sternum,⁴¹ pericardium,⁴¹ myocardium,⁴¹ endocardium,⁴¹ prostate,^{29 30 65} gallbladder,^{29 30 39 65} bile,^{30 39 65} myometrium,^{30 65 73} salpinges,^{30 65 73} ovaries,^{30 65 73} and appendix.^{1 60 65} Concentrations of the drugs in most of these tissues and fluids are 53–100% of concurrent serum concentrations.^{33 42 43 65}

Both ampicillin and sulbactam distributed into CSF in low concentrations following IV or IM administration.^{1 3 29 30 35 37 38 59 65} CSF concentrations generally higher in patients with inflamed meninges than in those with uninflamed meninges.^{35 37 38 59 65}

Ampicillin and sulbactam both readily cross the placenta^{3 30 65} and concentrations in umbilical cord blood may be similar to serum concentrations.⁶⁵ Ampicillin and sulbactam both distributed into milk in low concentrations.^{1 30 65 108}

Plasma Protein Binding

Ampicillin approximately 15–28% and sulbactam approximately 38% bound to serum proteins.^{1 3 29 33 65}

Elimination

Metabolism

Both ampicillin and sulbactam partially metabolized in the liver.³ Ampicillin partially metabolized by hydrolysis of the β-lactam ring to penicilloic acid which is microbiologically inactive.³

Elimination Route

Both ampicillin and sulbactam eliminated in urine principally by glomerular filtration and tubular secretion.^{3 29 30 33 34 46 65} Only small amounts of the drugs eliminated in feces and bile.^{3 33 45}

Following IM or IV administration in adults with normal renal function, approximately 75–92% of the dose of both ampicillin and sulbactam excreted unchanged in urine within 8 hours.^{1 65 67}

Ampicillin and sulbactam both removed by hemodialysis.^{1 34}

Half-life

In healthy adults with normal renal function, both ampicillin and sulbactam have a distribution half-life of about 15 minutes and an elimination half-life of about 1 hour.^{1 33 65 67}

In infants and children <12 years of age, sulbactam has an elimination half-life of 0.92–1.9 hours.^{29 32 33} In neonates, half-lives of ampicillin and sulbactam vary inversely with age; as renal tubular function matures, the drugs are cleared more rapidly.^{33 40 65 66} In premature neonates ≤6 days of age, half-life of ampicillin averages 9.4 hours and half-life of sulbactam averages 7.9 hours.²⁹

Special Populations

Half-lives are slightly longer in geriatric adults than in younger adults^{3 29 31} (2.2 hours compared with 0.8–1.2 hours in younger adults).²⁹

Serum concentrations of both ampicillin and sulbactam are higher and half-lives prolonged in patients with renal impairment.^{1 3 29 30 33 34 65} Half-lives of ampicillin and sulbactam average 1.6 and 1.6 hours, respectively, in adults with Cl_cr 30–60 mL/minute and average 3.4 and 3.7 hours, respectively, in those with Cl_cr 7–30 mL/minute.³⁴ In adults with Cl_cr <7 mL/minute, elimination half-life of ampicillin and sulbactam average 17.4 and 13.4 hours, respectively.³⁴

Cystic fibrosis patients may eliminate sulbactam at faster rates than healthy individuals.^{29 32 65}

Stability

Storage

Parenteral

Powder for Injection or Infusion

≤30°C.¹

IV solutions containing 45 mg/mL (30 mg of ampicillin and 15 mg of sulbactam per mL) prepared using sterile water for injection or 0.9% sodium chloride injection are stable for 8 hours at 25°C or 48 hours at 4°C;¹ solutions containing 30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) are stable for 72 hours at 4°C.¹ IV solutions containing 45 mg/mL (30 mg of ampicillin and 15 mg of sulbactam per mL) in lactated Ringer’s injection or (1/6) M sodium lactate injection are stable for 8 hours at 25°C or for 24 or 8 hours, respectively, when refrigerated at 4°C.¹

IV solutions containing 30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) in 5% dextrose injection are stable for 2 hours at 25°C or 4 hours when refrigerated at 4°C; those containing 3 mg/mL (2 mg of ampicillin and 1 mg of sulbactam per mL) are stable for 4 hours at 25°C.¹

IV solutions in ADD-Vantage containers reconstituted with 0.9% sodium chloride injection to concentratons ≤30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) are stable for 8 hours at 25°C.¹ Final solutions should be completely administered within 8 hours to ensure proper potency.¹

IM solutions containing 375 mg/mL (250 mg of ampicillin and 125 mg of sulbactam per mL) prepared using sterile water for injection or 0.5 or 2% lidocaine hydrochloride injection should be used within 1 hour after reconstitution.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Sodium chloride 0.9%

Drug Compatibility

Admixture CompatibilityHID

Compatible
Aztreonam
Incompatible
Ciprofloxacin

Y-site CompatibilityHID

Compatible
Amifostine
Anidalufungin
Aztreonam
Bivalirudin
Cefepime HCl
Dexmedetomidine HCl
Docetaxel
Enalaprilat
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Filgrastim
Fluconazole
Fludarabine phosphate
Gallium nitrate
Gemcitabine HCl
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Linezolid
Meperidine HCl
Morphine sulfate
Paclitaxel
Pemetrexed sodium
Remifentanil HCl
Tacrolimus
Teniposide
Theophylline
Thiotepa
Incompatible
Amiodarone HCl
Amphotericin B
Cholesteryl sulfate complex
Ciprofloxacin
Fenoldopam mesylate
Fluconazole
Idarubicin HCl
Lansoprazole
Nicardipine HCl
Ondansetron HCl
Sargramostim
Variable
Diltiazem HCl
Vancomycin HCl

Actions and SpectrumActions

• 
  

  Fixed combination of ampicillin sodium (an aminopenicillin) and sulbactam sodium (a β-lactamase inhibitor).^{1 3}

  
  


• 
  

  Sulbactam synergistically expands activity of ampicillin against β-lactamase-producing bacteria by irreversibly and competitively inhibiting β-lactamases.^{1 3} Active against bacteria susceptible to ampicillin alone and also active against many β-lactamase-producing bacteria resistant to ampicillin alone.^{1 3}

  
  


• 
  

  Usually bactericidal.¹

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^{1 3}

  
  


• 
  

  Spectrum of activity includes many gram-positive and -negative aerobes and some anaerobes.^{1 3}

  
  


• 
  

  Gram-positive aerobes: active in vitro against β-lactamase-producing and non-β-lactamase-producing strains of Staphylococcus, S. epidermidis, and S. saprophyticus.¹ Also active in vitro against Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and Enterococcus faecalis.¹ Oxacillin-resistant (methicillin-resistant) staphylococci are resistant.³

  
  


• 
  

  Gram-negative aerobes: active in vitro against β-lactamase-producing and non-β-lactamase-producing strains of Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, and Neisseria gonorrhoeae.¹ Also active in vitro against P. vulgaris, Providencia rettgeri, P. stuartii, and Morganella morganii.¹ Inactive against Pseudomonas aeruginosa.¹

  
  


• 
  

  Anaerobes: active in vitro against Bacteroides (including B. fragilis),^{1 3} Clostridium, Peptococcus, and Peptostreptococcus.¹

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including ampicillin and sulbactam) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹

  
  


• 
  

  Importance of completing the entire prescribed course of treatment, even if feeling better after a few days.¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ampicillin and sulbactam or other antibacterials in the future.¹

  
  


• 
  

  Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ampicillin Sodium and Sulbactam Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	1 g (of ampicillin) and 0.5 g (of sulbactam) (labeled as a combined total potency of 1.5 g)*	Ampicillin and Sulbactam for Injection	Baxter
			Unasyn	Pfizer
		2 g (of ampicillin) and 1 g (of sulbactam) (labeled as a combined total potency of 3 g)*	Ampicillin and Sulbactam for Injection	Baxter
			Unasyn	Pfizer
		10 g (of ampicillin) and 5 g (of sulbactam) (labeled as a combined total potency of 15 g) pharmacy bulk package*	Ampicillin and Sulbactam for Injection	Baxter
			Unasyn	Pfizer
	For injection, for IV infusion	1 g (of ampicillin) and 0.5 g (of sulbactam) (labeled as a combined total potency of 1.5 g)	Unasyn	Pfizer
			Unasyn ADD-Vantage	Pfizer
			Unasyn Piggyback	Pfizer
		2 g (of ampicillin) and 1 g (of sulbactam) (labeled as a combined total potency of 3 g)	Unasyn	Pfizer
			Unasyn ADD-Vantage	Pfizer
			Unasyn Piggyback	Pfizer

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The Amer

Amphadase

Pronunciation: high-uhl-yur-AHN-ih-dase
Generic Name: Hyaluronidase
Brand Name: Examples include Amphadase and Vitrase

Amphadase is used for:

Increasing the absorption of other injected medicines or fluids.

Amphadase is a protein enzyme. It works by causing rapid spreading of injected fluid into the body, which increases the absorption of injected fluids.

Do NOT use Amphadase if:

• you are allergic to any ingredient in Amphadase

Contact your doctor or health care provider right away if any of these apply to you.

Before using Amphadase:

Some medical conditions may interact with Amphadase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a skin infection or skin cancer

Some MEDICINES MAY INTERACT with Amphadase. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Local anesthetics (eg, lidocaine) because risk of side effects of Amphadase may be increased


• Antihistamines (eg, diphenhydramine), certain hormones (eg, corticotropin, estrogens), cortisone, or salicylates (eg, aspirin) because the effectiveness of Amphadase may be decreased


• Benzodiazepines (eg, alprazolam), furosemide, or phenytoin because effectiveness may be decreased by Amphadase

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amphadase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amphadase:

Use Amphadase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• A skin test will be done before the first dose to see if you are allergic to Amphadase.


• Amphadase should not be applied directly in the eye, injected into a vein, or injected into skin that is infected, red, swollen, or irritated.


• If you miss a dose of Amphadase, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Amphadase.

Important safety information:

• Amphadase should not be used to enhance absorption of dopamine or alpha agonist medicines (eg, clonidine) or to reduce the swelling of bites or stings.


• LAB TESTS may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: It is unknown if Amphadase can cause harm to the fetus. If you become pregnant while taking Amphadase, discuss with your doctor the benefits and risks of using Amphadase during pregnancy. Amphadase does not cause problems during labor, but it is unknown if it can cause harm to the fetus during labor. Use caution if it is necessary to give Amphadase during labor. It is unknown if Amphadase is excreted in breast milk. If you are or will be breast-feeding while you are using Amphadase, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Amphadase:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Amphadase side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chills; dizziness; fainting; fast heartbeat; hives; nausea; rash; redness; swelling; vomiting.

Proper storage of Amphadase:

Amphadase is usually handled and stored by a health care provider. If you are using Amphadase at home, store Amphadase as directed by your pharmacist or health care provider. Keep Amphadase out of the reach of children and away from pets.

General information:

• If you have any questions about Amphadase, please talk with your doctor, pharmacist, or other health care provider.


• Amphadase is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Amphadase. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Amphadase resources

• Amphadase Side Effects (in more detail)
• Amphadase Use in Pregnancy & Breastfeeding
• Amphadase Drug Interactions
• Amphadase Support Group
• 0 Reviews for Amphadase - Add your own review/rating

• Amphadase Prescribing Information (FDA)


• Amphadase Consumer Overview


• Amphadase Advanced Consumer (Micromedex) - Includes Dosage Information


• Hyaluronidase Professional Patient Advice (Wolters Kluwer)


• Hylenex Consumer Overview


• Vitrase Prescribing Information (FDA)


• Vitrase Consumer Overview

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• Extravasation
• Hypodermoclysis
• Subcutaneous Urography

Amyl Nitrite Inhalant

Dosage Form: inhalant
Drug Facts Description: Amyl nitrite is a rapidly  acting vasodilator administered by inhalation.  0.3 ml is supplied in a covered thin glass capsule which is easily crushed between the fingers.  Amyl nitrite is a clear, yellowish liquid having a peculiar ethereal, fruity odor.  It is volatile, even at low temperatures, and is flammable.  This product is stabilized with Flexol(tm) 2 percent. The structural formula of amyl nitrite is:

Amyl nitrite causes a non specific relaxation of smooth muscle with the most prominent actions occurring in vascular smooth muscle.  This effect on vascular smooth muscle results in coronary vasodilation and decreased systemic vascular resistance and left ventricular preload and afterload.  Myocardial ischemia is relieved in patients with angina pectoris, with an abatement of chest pain and possibly other related symptons. Amyl nitrite vapors are absorbed rapidly through the pulmonary alveoli, manifesting therapeutic effects within one minute after inhalation.  The drug is metabolized rapidly, probably by hydrolytic denitration; approximately one-third of the inhaled amyl nitrite is excreted in the urine.

Amyl nitrite is indicated for the rapid relief of angina pectoris.  Its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes.

Since it may increase intraocular and intracranial pressures, amyl nitrite is contraindicated or should be used with great caution in patients with glaucoma, recent head trauma or cerebral hemorrhage.  Amyl nitrite can cause harm to the fetus when it is administered to a pregnant woman because it significantly reduces systemic blood pressure and blood flow on the maternal side of the placenta.

Transient episodes of dizziness, weakness, or syncope or other signs of cerebral ischemia due to postural hypotension may develop following inhalation of amyl nitrite, particularly if the patient is standing immobile.  To hasten recovery, measures which facilitate venous return such as head low posture, deep breathing and movement of extremities may be used.

Amyl nitrite is very flammable.  Do not use where it might become ignited.  General - Tolerance to amyl nitrite may develop with repeated use of the drug for prolonged periods of time.  Tolerance may be minimized by beginning with the smallest effective dose and alternating the drug with another coronary vasodilator.  High doses of nitrites may produce methemoglobinemia, especially in individuals with methemoglobin reductase deficiency or other metabolic abnormality that interferes with the normal conversion of methemoglobin back to hemoglobin. Patient Information - Amyl nitrite should be taken by the patient when seated or lying down. Drug Interactions - Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse.  Carcinogenesis, Mutagenesis, Fertility Impairment - Adequate long term studies to establish adverse carcinogenic potential of this drug have not been reported. Pregnancy - Teratogenic effects. Category C. Animal studies have not been conducted with amyl nitrite.  It is also not known whether amyl nitrite can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amyl nitrite should be given to a pregnant woman only if clearly needed. Nursing Mothers - It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when amyl nitrite is administered to a nursing woman. Pediatric Use - Safety and effectiveness in children have not been established.

Mild transitory headache, dizziness and flushing of the face are common with the use of amyl nitrite.  The following adverse reactions may occur in susceptible patients syncope, involuntary passing of urine and feces, hypotension, pallor, cold sweat, tachycardia, restlessness, weakness, vomiting and nausea.  Excessively high doses of amyl nitrite administered chronically may cause methemoglobinemia.

Abuse. Volatile nitrites are abused for sexual stimulation, with headache as a common side effect. Dependence. Tolerance to nitrites can develop conditions and duration have not been established.

Symptons. Inhaled doses of 5 to 10 drops of amyl nitrite may cause violent flushing of the face, accompanied by a feeling of imminent bursting of the head and very excessive heart action. The inhalation of larger amounts may produce a feeling of suffocation and muscular weakness. Symptons comparable to shock may be produced such as weakness, restlessness sweating pallor nausea vomiting snycope and incontinence attributable to pooling of blood in the postarteriolar vessels and failure of the venous blood to return to the heart.  Treatment. Measures which facilitate venous return such as head low posture, deep breathing and movement of extremities may be used. The use of epinephrine aggravates the shock like reaction. Methylene blue should be injected for treatment of severe methemoglobinemia with dyspnea. For treating cyanide poisoning, methylene blue is contraindicated where nitrites cause iatrogenic methemoglobinemia.

With the patient in recumbent or seated position a capsule of amyl nitrite is held away from the face, crushed between the fingers, and held under the patient's nose. Two to six inhalations of the vapors from the capsule are usually sufficient to promptly produce therapeutic effects. Caution is recommended to avoid inhalation of excessive amounts of the drug when it is administered by someone other than the patient. If necessary, the dose may be repeated in 3 to 5 minutes.

James Alexander brand amyl nitrite is furnished in covered glass capsules. Each capsule contains 0.3 ml in boxes of 12. The capsule contents are flammable and should be protected from light. Storage should be in a cold place. 2 - 8 C 36 to 46 F. The James Alexander Corporation Blairstown, NJ 07825.

Amyl Nitrite Inhalants, USP each ampule contains 0.3 ml For Inhalation Only A rapidly acting vasodilator used for angina pectoris. Directions. Crush a covered ampule between fingers held away from the face. Hold to nostrils and carefully inhale vapor.

Keep away from open flame or spark 12 boxes each containing 12 crushable ampules with protective covering Amyl Nitrite Inhalants USP Each ampule contains 0.3 ml for inhalation only store in a cold place between 2C and 8C Keep out of reach of children.

AMYL NITRITE  amyl nitrite  inhalant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 46414-2222 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amyl Nitrite (Amyl Nitrite) Amyl Nitrite 0.3 g  in 0.3 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46414-2222-8 144 AMPULE In 1 CARTON contains a AMPULE (46414-2222-1) 1 46414-2222-1 0.3 mL In 1 AMPULE This package is contained within the CARTON (46414-2222-8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/07/1979

Labeler - James Alexander Corporation (040756421)

Registrant - James Alexander Corporation (040756421)

Establishment
Name	Address	ID/FEI	Operations
James Alexander Corporation		040756421	manufacture

Revised: 07/2010James Alexander Corporation

More Amyl Nitrite Inhalant resources

• Amyl Nitrite Inhalant Side Effects (in more detail)
• Amyl Nitrite Inhalant Use in Pregnancy & Breastfeeding
• Amyl Nitrite Inhalant Drug Interactions
• Amyl Nitrite Inhalant Support Group
• 0 Reviews for Amyl Nitrite Inhalant - Add your own review/rating

Compare Amyl Nitrite Inhalant with other medications

• Angina
• Cyanide Poisoning

Amturnide

Generic Name: aliskiren, amlodipine, and hydrochlorothiazide (Oral route)

a-lis-KYE-ren, am-LOE-di-peen BES-i-late, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

When pregnancy is detected, discontinue aliskiren/amlodipine/hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

• Amturnide

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Renin Inhibitor

Chemical Class: Amlodipine

Uses For Amturnide

Aliskiren, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Aliskiren is a renin inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using Amturnide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren, amlodipine, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren, amlodipine, and hydrochlorothiazide combination in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetyldigoxin


• Amiodarone


• Arsenic Trioxide


• Atazanavir


• Conivaptan


• Cyclosporine


• Dantrolene


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Flecainide


• Itraconazole


• Ketanserin


• Levomethadyl


• Lithium


• Metildigoxin


• Ouabain


• Proscillaridin


• Simvastatin


• Sotalol


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alacepril


• Alprenolol


• Apazone


• Aspirin


• Atenolol


• Benazepril


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Captopril


• Carbamazepine


• Carteolol


• Carvedilol


• Celecoxib


• Celiprolol


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Clopidogrel


• Cyclophosphamide


• Dalfopristin


• Delapril


• Diclofenac


• Diflunisal


• Dilevalol


• Diltiazem


• Enalapril


• Enalaprilat


• Enalapril Maleate


• Esmolol


• Etodolac


• Fenoprofen


• Fluconazole


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imatinib


• Imidapril


• Indinavir


• Indomethacin


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moexipril


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nepafenac


• Oxaprozin


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piroxicam


• Propranolol


• Quinapril


• Quinupristin


• Ramipril


• Rifampin


• Rifapentine


• Ritonavir


• Salicylic Acid


• Salsalate


• Sotalol


• Spirapril


• St John's Wort


• Sulindac


• Talinolol


• Temocapril


• Tertatolol


• Timolol


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition occurring again.

• Anuria (not able to pass urine) or


• Kidney disease, severe or


• Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Asthma, history of—May increase likelihood of having an allergic reaction.

• Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Systemic lupus erythematosus (SLE)—Use with caution. May make this condition worse.

Proper Use of Amturnide

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

This medicine comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food, but try to take it consistently. High-fat meals may affect absorption of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For high blood pressure:
    
    • Adults—Your doctor will determine your starting dose and may increase your dose as needed. However, the dose is usually not more than 300 milligrams (mg) of aliskiren, 10 mg of amlodipine, and 25 mg of hydrochlorothiazide once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Amturnide

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant (especially in your second or third trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Stop using this medicine and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

You should not use this medication (unless your doctor specifically tells you to) if you are also receiving itraconazole (Sporanox®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), or lithium (Eskalith®, Lithobid®).

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack, especially in patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort; fast or irregular heartbeat; nausea or vomiting; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; or sweating.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs. Do not use salt substitutes containing potassium without first checking with your doctor.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Amturnide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• rapid weight gain


• tingling of hands or feet


• unusual weight gain or loss

Less common

• Dizziness

Rare

• Blurred vision


• confusion


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• sweating


• unusual tiredness or weakness

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Fever


• headache


• muscle aches


• sore throat


• stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Amturnide side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Amturnide resources

• Amturnide Side Effects (in more detail)
• Amturnide Dosage
• Amturnide Use in Pregnancy & Breastfeeding
• Drug Images
• Amturnide Drug Interactions
• Amturnide Support Group
• 0 Reviews for Amturnide - Add your own review/rating

• Amturnide Prescribing Information (FDA)


• Amturnide MedFacts Consumer Leaflet (Wolters Kluwer)


• Amturnide Consumer Overview

Compare Amturnide with other medications

• High Blood Pressure

An-DTPA

Generic Name: technetium tc 99m pentetate (Intravenous route)

tek-NEE-shee-um Tc 99m PEN-te-tate

Commonly used brand name(s)

In the U.S.

• An-DTPA


• MPI DTPA

Available Dosage Forms:

• Kit

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For An-DTPA

Technetium Tc 99m pentetate injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Technetium Tc 99m pentetate injection is used to help your doctor see an image of your kidneys and assess how well they are working. It is also used to help your doctor see an image of your brain.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using An-DTPA

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of technetium Tc 99m pentetate injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of technetium Tc 99m pentetate injection in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The image quality of the kidney or brain scan may be affected in patients with this condition.

Proper Use of technetium tc 99m pentetate

This section provides information on the proper use of a number of products that contain technetium tc 99m pentetate. It may not be specific to An-DTPA. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins before you have a brain or kidney scan.

You will need to urinate right away and as often as possible for 4 to 6 hours after receiving this medicine. Drink plenty of fluids before and after receiving this medicine so you will pass more urine.

Precautions While Using An-DTPA

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

An-DTPA Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Cough


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• hives


• itching


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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